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Bosch makes liquid filling a disposable option

03-Apr-2008 - The use of disposable manufacturing equipment in pharmaceutical production and greater need for containment equipment were recurring themes at the Interphex show in Philadelphia last week, and both were addressed by new equipment from Bosch Packaging Technology.

Waters Patrol keeps a close eye on PAT

02-Apr-2008 - Waters Corp unveiled a new concept in Process Analytical Technology (PAT) at Pittcon 2008 when it released the new Patrol UPLC (ultra performance liquid chromatography) process analyser, which can be incorporated directly into a process.

Microbial testing steps up a gear with Growth Direct

02-Apr-2008 - With manufacturing productivity in the pharmaceutical sector widely acknowledged as being in need of modernisation, a US firm believes it has developed a technology that could carve days off the time spent on microbial testing, a cumbersome but ubiquitous part of the quality control process.

China watchdog responds to heparin scare; AZ now affected

30-Mar-2008 - China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.

SemBioSys prepares to file novel insulin product with FDA

27-Mar-2008 - Canada's SemBioSys Genetics has begun final pre-clinical studies of its novel plant-produced insulin product in preparation for its submission to US regulatory authorities.

FDA deadlines compromise drug safety

27-Mar-2008 - New research has shown that the FDA's strict 10-month deadline for a drug's approval following submission may compromise drug safety and lead to insufficient data for precise drug administration.

No joy for MHRA but tighter rules for pharma following Seroxat probe

27-Mar-2008 - The pharmaceutical industry in the UK faces tougher legislation on the disclosure of adverse events in clinical trials following the MHRA's thwarted attempt to prosecute GlaxoSmithKline for allegedly withholding information about risks of suicidal behaviour in children and adolescents taking its antidepressant Seroxat (paroxetine).

EU's ageing science workforce could damage future innovations

27-Mar-2008 - The ageing population of the European Union (EU) could result in a stagnation in technological innovation, according to a new report. As science and technology professionals get older and less socially mobile, there are fears that it could result in a loss in scientific expertise.

Record R&D investment in US

27-Mar-2008 - Research and development investment by America's pharmaceutical and biotechnology research companies reached a record $58.8bn last year, a rise of $3bn since 2006.

New US biosimilars bill a disappointing distraction, says GPhA

26-Mar-2008 - The generic pharmaceutical industry has given short shrift to the latest congressional attempt to construct a viable approval pathway for biosimilars in the US.

UK pharma industry set to lose business offshore

26-Mar-2008 - The pharmaceutical industry has lost confidence in the UK as a place to do business to an "alarming degree" and the situation is only set to deteriorate, reveals new research.

Heparin recall widens in US

25-Mar-2008 - The heparin recall has widened after a lot of heparin sodium USP active pharmaceutical ingredient (API) produced by Scientific Protein Laboratories (SPL) was found to contain a heparin-like contaminant.

FDA identifies heparin contaminant; confirms China link

20-Mar-2008 - The US Food and Drug Administration (FDA) has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.

Commission sets out its stall on anti-counterfeiting measures

19-Mar-2008 - Batch pedigrees, obligatory product seals, mass serialisation, mandatory audits and tighter requirements for the manufacture, import, export and transportation of medicinal products are among the legislative steps being considered by the European Commission to counter the growing threat of counterfeit drugs in the EU.

Revised glycerin monograph announced to combat contamination

19-Mar-2008 - A revised glycerin monograph has been announced at the US Pharmacopeial (USP) Convention which it is hoped will further decrease the likelihood of health hazards associated with diethylene glycol-contaminated glycerin.

GMP an unnecessary burden for excipients, review concludes

17-Mar-2008 - The costs of introducing any formal good manufacturing practice (GMP) requirements for potentially high-risk pharmaceutical excipients in the European Union would far exceed the likely benefits, concludes an impact assessment for the European Commission.

Pharmaceutical traces in water 'highly unlikely to harm', says industry

12-Mar-2008 - Politicians in the US have gone on the offensive while regulators and industry groups have circled their wagons over a five-month investigation by the Associated Press that has rung alarm bells about trace levels of pharmaceuticals in drinking water.

Heparin contamination emerges after FDA China investigation

07-Mar-2008 - A US Food and Drug Administration (FDA) investigation into the recent Baxter heparin scare has uncovered a contaminant in the product that was sourcing the active pharmaceutical ingredient (API) from a Chinese manufacturer.

Direct particle analysis at the nano level

06-Mar-2008 - A joint development partnership between Malvern Instruments and imaging specialist FEI has produced what the companies claim is the first ever tool for determining the size and shape of sub-micron particles through direct analysis.

Operation Jupiter rains on fake antimalarials

28-Feb-2008 - A multinational, multidisciplinary initiative involving scientists, public health workers, police and government officials could provide a cogent model for rooting out and stamping out counterfeiting of essential and lifesaving drugs.

New device uses spectroscopy to speed up particle ID

21-Feb-2008 - Germany's rap.ID Particle Systems has launched a new lab-ready particle identification device capable of identifying around 400 particles an hour from 5µm and up. The company says the device is suited for development and quality assurance in the pharmaceutical industry.

Warning for Vintage generic drugmaker

20-Feb-2008 - Generic drug manufacturer Vintage Pharmaceuticals has fallen foul of the regulatory authorities in the US once again for failing to meet quality standards.

Fentanyl patches recalled over leakage risk

20-Feb-2008 - Concerns have been building across North America about the safety of transdermal patches for delivering the highly potent narcotic analgesic fentanyl.

North American water treatment market on a growth track

19-Feb-2008 - With 40-60 per cent of a global drug manufacturing industry worth more than $380bn captured by the North American marketplace, the region offers sustained opportunities for suppliers of pharmaceutical water and wastewater treatment solutions to increase their revenues while improving market share and brand recognition.

FDA starts inspecting stalled Watson facility

18-Feb-2008 - An end may be in sight to the long-running problems with the Florida manufacturing facility acquired by US brand and generic company Watson Pharmaceuticals with Andrx Corporation in November 2006.

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